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Abstract:

A method of improving health in an animal includes administering to the
animal a nutritional supplement comprising an amino acid secretagogue
composition, which stimulates the pituitary gland in the animal to
produce growth hormone. The nutritional supplement may be administered
orally. The nutritional supplement may comprise L-arginine hydrochloride,
L-pyroglutamic acid, L-lysine hydrochloride, and cysteine. When desired,
the nutritional supplement may consist essentially of L-arginine
hydrochloride, L-pyroglutamic acid, L-lysine hydrochloride,
N-acetyl-L-cysteine, L-glutamine, and schizonepeta powder.

15. The method of claim 11, wherein administering the nutritional
supplement comprises administering about 20-50 gms/kg of body weight of
the nutritional supplement.

16. The method of claim 11, wherein the nutritional supplement is in
powder, tablet, capsule, liquid, or wafer form.

17. The method of claim 11, wherein the nutritional supplement is
administered once a week or once a month.

18. The method of claim 11, wherein the nutritional is administered one
to three times daily.

19. The method of claim 11, wherein the nutritional supplement is
administered on an empty stomach.

20. The method of claim 11, wherein the nutritional supplement is
administered for at least one of following in the animal: increasing
growth performance, enhancing lean body mass, improving reproductively
performance, stimulating milk production, boosting milk yield, and
increasing a feed efficiency.

Description:

TECHNICAL FIELD

[0001] Embodiments of the present disclosure generally relate to methods
and nutritional supplements for improving health in animals.

BACKGROUND

[0002] Growth hormone is an anabolic hormone capable of promoting linear
growth, weight gain and whole body nitrogen retention in animals. Growth
hormone is produced in somatotroph cells of the anterior pituitary gland
of animals and secreted throughout life. It is mainly controlled in the
brain by two hypothalamic peptides: growth hormone releasing hormone
(GHRH), which stimulates its secretion and synthesis; and somatostatin,
which inhibits them. Growth hormone is known to promote skeletal growth,
to increase nitrogen retention and protein synthesis, and to affect
glucose and lipid metabolism in animals.

[0003] As animal grows older, the growth hormone undergoes considerable
decrement resulting in a loss of skeletal muscle mass, osteoporosis,
increased fat deposition and decreased lean body mass. It has been
demonstrated that the development of these changes can be offset by
recombinant growth hormone therapy. However, current recombinant growth
hormone therapy has several shortcomings including frequent subcutaneous
or intravenous injections, insulin resistance and impaired glucose
tolerance.

[0004] Growth hormone has been administered to animals to offset the
growth hormone deficiency in aged animals. Furthermore, there are reports
of using growth hormone to boost certain desirable performances of
animals. For example, growth hormone has been used to enhance growth
performance in animals by increasing lean body mass with an overall
improvement in feed efficiency, and to enhance fertility in animals.
Additionally, growth hormone has been used to stimulate milk production
and achieve an enhanced milk yield in mammals.

[0005] U.S. Pat. No. 4,521,409, issued on Jun. 4, 1985 to Bauman, and U.S.
Pat. No. 5,004,728, issued on Apr. 2, 1991 to Chalupa disclose the
administration of growth hormone to cattle and ruminants to stimulate
milk production with an increase in feed to milk conversion. In U.S. Pat.
No. 5,416,073, issued on May 16, 1995 to Coy, growth hormone is used to
increase milk production in dairy cows and to increase growth rates in
animals such as cattle, sheep, and swine.

[0006] U.S. Pat. No. 5,008,244, issued on Apr. 16, 1991 to Miller
discloses an administration of growth hormone to food-producing animals
to increase their fertility by improving embryonic survival and litter
size during the reproductive stage of growth. In U.S. Pat. No. 5,583,106,
issued on Dec. 10, 1996 to Stanisiewski, an enhanced reproductive
performance in cattle is achieved by commencing administration of growth
hormone during the early postpartum period.

[0007] U.S. Pat. No. 5,637,566, issued on Jun. 10, 1997 to Walker et al.
describes the use of growth hormone to improve carcass quality and/or
food conversion efficiency in animals. In U.S. Pat. No. 4,792,546, issued
on Dec. 20, 1988 to Baker, growth hormone is administered to
food-producing animals to increase weight gain and at the same time
reduce fat deposition and improve the lean meat to fat ratio.

SUMMARY OF THE DISCLOSURE

[0008] The present disclosure includes a nutritional supplement and a
method of using the same for improving health in animals. The nutritional
supplement is an amino acid secretagogue composition, which stimulates
the pituitary gland of animals to release growth hormone.

[0009] A particular embodiment of the present disclosure relates to a
nutritional supplement for improving health in animals, the nutritional
supplement comprising L-arginine, L-pyroglutamic acid, L-lysine, and
cysteine.

[0011] Other embodiments are drawn to methods of increasing growth hormone
in animals, the methods including administering the disclosed nutritional
supplement to an animal. In particular embodiments, the method includes
orally administering the disclosed nutritional supplement to an animal.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0012] The present disclosure relates to methods and nutritional
supplements for improving health in animals. The nutritional supplement
is an amino acid secretagogue composition, which stimulates the pituitary
gland in an animal to produce growth hormone. Increased production of
growth hormone in animals may prevent the loss of skeletal muscle mass,
osteoporosis, increased fat deposition, decreased lean body mass, and
other disorders. The supplement of the present disclosure may work as a
dietary supplement by assisting the animal's ability to secrete growth
hormone naturally in a manner which is safe and effective.

[0013] As used herein, the term "animal" means any species of the kingdom
Animalia, including mammals, avians, reptiles or amphibians. It may
include a food-producing animal (e.g., chicken, turkeys, ducks, geese,
guinea henspig, cattle, lambs, fish, etc.); a pet such as dog and cat; or
a working animal such as horse.

[0014] As used herein, the term "mammal" means a warm blooded vertebrate,
including non-human animals such as murine, porcine, canine and feline.
It may include ungulates or hooved animals (e.g., cattle, goats, pigs,
horse, sheep, etc.); rodents (e.g., guinea pigs, hamsters, mice, rats,
etc.); lagomorphs such as rabbits; primates (e.g., monkeys, baboons,
humans, etc.); or the like. By way of non-limiting examples, mammal may
include cattle, sheep, goat, or swine.'

[0015] A particular embodiment of the present disclosure relates to a
nutritional supplement for improving health of animals, the nutritional
supplement including L-lysine, L-arginine, oxo-proline, and at least one
of cysteine and glutamine. The supplement may additionally include both
cysteine and glutamine and/or schizonepeta powder. In particular
embodiments, a functional dosage may include L-arginine at a level
between 0.1-6 mmol, oxo-proline at a level between 0.1-8 mmol, and/or the
L-lysine in an amount between 0.1-12 mmol. The cysteine and/or glutamine
may be contained at a level between 0.001-6 mmol. The cysteine may be
n-acetyl L-cysteine, and the glutamine may be L-glutamine. The amino
acids may be delivered as non-toxic salts thereof, effective complexes
thereof, stable chelates thereof, active esters thereof, functional
derivatives thereof, or mixtures thereof, which are effective to increase
growth hormone levels in animals. The nutritional supplement may be
present in an amount of 2.9 grams. Dosages are generally calculated in
the range of about 20-50 gms per kg of body weight of the animal. The
nutritional supplement may be administered to animals orally. The
supplement may be in any acceptable and known oral formulation including,
but are not limited to, powder, tablet, capsule, or liquid form.

[0016] Another particular embodiment relates to a nutritional supplement
for improving health of animals, the nutritional supplement consisting
essentially of L-lysine HCl, L-arginine HCl, oxo-proline, N-acetyl
L-cysteine, L-glutamine, and schizonepeta (aerial parts) powder. In
particular embodiments, a functional dosage may include L-arginine HCl at
a level between 0.1-6 mmol, and oxo-proline at a level between 0.1-8
mmol, and/or the L-lysine HCl in an amount between 0.1-12 mmol. The
n-acetyl L-cysteine and/or L-glutamine may be contained at a level
between 0.001-6 mmol. In another particular embodiment, a functional
dosage may include L-arginine HCl at a level between 2.5-4.5 mmol,
oxo-proline between 4-6 mmol, and/or the L-lysine HCl in an amount
between 7-9 mmol. The n-acetyl L-cysteine and/or L-glutamine may be
contained at a level between 0.001-0.5 mmol. The nutritional supplement
may be administered to animals orally. The supplement may be in any
acceptable and known oral formulation including, but are not limited to,
powder, tablet, capsule, or liquid form.

[0017] Other embodiments are drawn to methods of increasing growth hormone
in animals, the methods including administering the disclosed nutritional
supplement to an animal. In particular embodiments, the method includes
orally administering the disclosed nutritional supplement to an animal.
The amount of dosage and frequency of administration may be varied
according to many factors including, but are not limited to, animal
species, ages and health.

[0019] In accordance with the "consist essentially of" and "consisting
essentially of" language, the nutritional supplement is essentially
limited to the aforementioned ingredients and does not include any
additional active ingredients intended to add nutritional content (e.g.,
vitamins, minerals, etc.), but may include additional ingredients not
intended to add nutritional content such as ingredients intended to
fulfill a non-nutritional purpose (e.g., coloring, fillers, flavoring, an
ingredient for maintaining the structural form, etc.).

[0020] Each ingredient of the nutritional supplement may be prepared in
accordance with any method known to one of ordinary skill in the art.
Alternatively, each ingredient may be obtained in a fully prepared from a
commercially available source.

[0021] The nutritional supplement may be in any suitable oral
administration form, including but not limited to: a chewable form, a
liquid form, a spray form, a capsule form, a suppository form,
dissolvable wafer, and a powder form.

[0022] Irrespective of the structural form of the nutritional supplement,
the ingredients of the nutritional supplement may be distributed
homogeneously or non-homogeneously within the nutritional supplement.

[0023] The nutritional supplement may be administered to an animal on a
regular basis, such as a weekly or monthly intake at a dosage tailored to
the animal's needs; i.e., the nutritional supplement may be administered
regularly as multiples (1×, 2×, etc.) of the structural units
(pills, tablets, capsules, etc.) in accordance with the needs of the
animal. For example, an elderly animal is likely to need higher daily
doses than does a young animal. Alternatively, the nutritional supplement
may be administered on an as-needed basis at a dosage tailored to the
animal's needs, such as administering the nutritional supplement to
cattle during the early postpartum period to enhance reproductively
performance. Veterinarian counseling may be beneficial for arriving at a
desirable or optimal dosage tailored to the animal's needs.

[0024] The combination of types of amino acids, mass ranges, and specific
formulations may be selected to be synergistically balanced and of
adequate quantity to achieve the desired physiological effect, namely,
growth hormone release. Improper combinations of the amino acids may be
ineffective. The component amino acids are synergistic in the sense that
several of them when combined together, synergistically stimulate the
release of human growth hormone. The combination may also be chosen to
reduce or inhibit chemical combination or reaction between the amino
acids.

EXAMPLES

Example 1

[0025] The short-term effects of the disclosed supplement on the growth
hormone level in animals are tested two hours after administration. The
animal subjects are administered the capsules of supplement
(SeroVital®) or an identical looking placebo. SeroVital® is a blend
of l-lysine HCl, l-arginine HCL, oxo-proline, N-acetyl-1-cysteine,
l-glutamine, and schizonepeta (aerial parts) powder. Animal subjects are
administered approximately 35 gms per kg of body weight. Blood is drawn
at 15, 30, 60 and 90 and 120 minutes for assay. The growth hormone level
is measured at each time point using the Siemens Immulite 2000
(intra-assay CV was 3.72%, inter-assay CV was 5.70%, and the detection
limit for GH was 0.05ng/ml). The 15 and 120 minute time points are
additionally assayed for triiodothyronine (T3) as informative for
mechanistic investigations.

[0026] The mean growth hormone in the animal subjects are increased more
than 600% after the administration of supplement from 0.17 at baseline to
1.33ng/ml at 120 minutes, while there is are no increases observed in the
mean growth hormone of the animal subjects after the administration of
placebo.

[0027] The growth hormone levels from baseline to 120 minutes (the growth
hormone level at 120 minutes minus the growth hormone level at 0 minute),
are increased about two fold when compared to the administration of a
placebo. Overall, 120 minutes after the administration of the supplement,
the growth hormone levels are significantly higher in absolute levels or
by AUC.

[0028] Furthermore, the animals that were administered SeroVital® will
exhibit a deceased reduction in T3 by nearly one-half over the same time
period, compared to the animals administered with the placebo. These
results affirm that somatostatin inhibition plays a mechanistic role in
the ability of SeroVital® to induce significant increases in serum
growth hormone levels in animal subjects.

[0030] The effect of the nutritional supplement on endurance and fat
metabolism in animals are investigated. Each animal subject is measured
for baseline weight, height, body fat percent and resting metabolic rate.
Then, each animal subject is administered with the supplement
SeroVital®, which is a blend of l-lysine HCl, l-arginine HCl,
oxo-proline, N-acetyl-1-cysteine, l-glutamine, and schizonepeta (aerial
parts) powder for 2 weeks before being measured again for weight, height,
body fat percent and resting metabolic rate. The measurements before and
after the administration of the supplement are analyzed.

[0031] Mean VO2max of the animal subjects increases compared to
baseline. After the period of supplementation with SeroVital®, the
mean RMR increases compared to baseline (P=0.165). Estimated daily
calorie expenditure also increases.

[0032] After two weeks of supplementation with the supplement
SeroVital®, both RMR and estimated daily calorie expenditure of the
animal subjects tend to increase, evidencing the potential of the
supplement to impart long-term fat burning effects. Additionally,
endurance as measured by VO2max in the post-absorptive state
significantly improves. Overall, the animal subjects administered with
the SeroVital® supplement will show enhanced parameters of endurance,
energy, and vitality.

Example 3

[0033] The effect of the nutritional supplement on lean body mass and
weight change of animals is studied. The animal subjects in the first
group are given daily doses of the nutritional supplement for 6 months at
different dosing concentrations of active ingredients, while the animal
subjects in the second group are given placebo. Weight, percent lean body
mass, and percent fat body mass are chosen as primary measures of body
composition at the 6 month analysis period. The weight, body composition,
and physical performance (including endurance) of the animal subjects are
determined before and after the treatment, along with hormonal data
analysis.

[0034] The animal subjects treated with the nutritional supplement show a
sustained increase in lean body mass and an improved physical
performance.

[0035] While embodiments of the present invention have been described
herein for purposes of illustration, many modifications and changes will
become apparent to those skilled in the art. Accordingly, the appended
claims are intended to encompass all such modifications and changes as
fall within the true spirit and scope of this invention.